Trial Outcomes & Findings for Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy (NCT NCT03819114)
NCT ID: NCT03819114
Last Updated: 2021-12-27
Results Overview
AUC for each participant was calculated from all available LNG concentrations measured over 8 hours using the linear up/log down version of trapezoidal rule (i.e., noncompartmental technique) using the software package Phoenix WinNonLin (Certara®). This version of the trapezoidal rule used linear interpolation between untransformed data up to Cmax, and between log-transformed data from Cmax through Clast. Assay lower limit of quantification (LLOQ) for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours post-dose
Results posted on
2021-12-27
Participant Flow
Participants enrolled from 18 sites. Sites were located in the United States and internationally (Botswana, Brazil, Kenya, Malawi, South Africa, Thailand). The first participant accrued in May 2019, and the last participant accrued in November 2020.
Participants receiving EFV-based ART therapy were randomized between Group A (1.5mg dose of LNG) and Group B (3.0mg dose of LNG) in a 1:2 ratio using permuted blocks and institutional balancing. Participants living with HIV receiving DTG-based ART therapy and participants with TB receiving RIF-INH therapy were assigned to study groups C and D, respectively. Women with BMI greater than or equal to 30 kg/m2 were limited to no more than 5 within Groups B-D and no more than three within Group A.
Participant milestones
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
36
|
35
|
34
|
|
Overall Study
Received LNG Treatment
|
17
|
36
|
35
|
34
|
|
Overall Study
COMPLETED
|
17
|
35
|
33
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy
Baseline characteristics by cohort
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42 years
n=5 Participants
|
36 years
n=7 Participants
|
34 years
n=5 Participants
|
25 years
n=4 Participants
|
34 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black (Non-Hispanic)
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino (Regardless of race)
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White (Non-Hispanic)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Botswana
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
Kenya
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Malawi
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Region of Enrollment
South Africa
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Region of Enrollment
Thailand
|
9 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Gender Identity
Cisgender
|
17 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Gender Identity
Transgender spectrum
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
HIV-1 Infection Status
HIV-1 infection present
|
17 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
HIV-1 Infection Status
HIV-1 infection absent
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours post-dosePopulation: Participants who took assigned dose of LNG and prescribed doses of background drugs (ART or TB treatment) and who had LNG PK concentrations available over the sampling time frame.
AUC for each participant was calculated from all available LNG concentrations measured over 8 hours using the linear up/log down version of trapezoidal rule (i.e., noncompartmental technique) using the software package Phoenix WinNonLin (Certara®). This version of the trapezoidal rule used linear interpolation between untransformed data up to Cmax, and between log-transformed data from Cmax through Clast. Assay lower limit of quantification (LLOQ) for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
LNG Area Under the Concentration-time Curve (AUC0-8h) Calculated Based on Intensive LNG PK Samples Obtained From Individual Participants
|
52.13 hours * ng/mL
Interval 36.72 to 88.27
|
102.13 hours * ng/mL
Interval 64.52 to 114.75
|
80.50 hours * ng/mL
Interval 66.64 to 125.06
|
124.39 hours * ng/mL
Interval 87.1 to 168.79
|
SECONDARY outcome
Timeframe: From Day 0 through study Day 28Population: Participants who received LNG study treatment, grouped by LNG dose. LNG 1.5mg includes Group A (LNG 1.5 mg Among Participants on EFV-based ART (Randomized)) and Group C (LNG 1.5 mg Among Participants on DTG-based ART (Assigned)) participants. LNG 3.0mg includes Group B (LNG 3.0 mg Among Participants on EFV-based ART (Randomized)) and Group D (LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)) participants.
Adverse events were Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 and DAIDS AE Grading Table Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007. Relationship of AE to study treatment was determined by the site, study core team, and DAIDS clinical representative. AEs evaluated in this outcome fulfilled the below criteria: * Potentially or definitely related to LNG dose * Grade 3 or higher AEs * Grade 2 of higher nausea, diarrhea, menorrhagia or metrorrhagia, and ectopic pregnancies
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=52 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=70 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Number and Percentage of Participants Experiencing Either a Serious Adverse Event (SAE) or Adverse Event (AE) Potentially or Definitely Associated With Single Dose LNG Administration.
|
2 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours post-dosePopulation: Participants who took assigned dose of LNG and prescribed doses of background drugs (ART or TB treatment) and who had LNG PK concentrations available over the sampling time frame.
Cmax for each participant was calculated as the maximum observed LNG concentration from LNG PK samples at pre-dose through 48 hours post-dose. Standard noncompartmental techniques were used to determine Cmax using the software package Phoenix WinNonLin (Certara®).
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Maximum Concentration (Cmax) of LNG
|
15.10 ng/mL
Interval 11.2 to 24.0
|
24.90 ng/mL
Interval 16.2 to 29.6
|
18.65 ng/mL
Interval 14.05 to 26.15
|
28.01 ng/mL
Interval 23.0 to 39.6
|
SECONDARY outcome
Timeframe: Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours post-dosePopulation: Participants who took assigned dose of LNG and prescribed doses of background drugs (ART or TB treatment) and who had LNG PK concentrations available over the sampling time frame.
Cmin for each participant was calculated as the minimum observed LNG concentration from LNG PK samples at pre-dose through 48 hours post-dose. Standard noncompartmental techniques were used to determine Cmin using the software package Phoenix WinNonLin (Certara®). Assay lower limit of quantification for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Minimum Concentration (Cmin) of LNG
|
0.25 ng/mL
Interval 0.13 to 0.37
|
0.56 ng/mL
Interval 0.19 to 1.08
|
1.49 ng/mL
Interval 0.8 to 3.07
|
0.41 ng/mL
Interval 0.17 to 0.74
|
SECONDARY outcome
Timeframe: Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours post-dosePopulation: Participants who took assigned dose of LNG and prescribed doses of background drugs (ART or TB treatment) and who had LNG PK concentrations available over the sampling time frame.
Apparent oral clearance (CL/F) for each participant was calculated as CL/F = dose/AUC0-24 or CL/F = dose/AUC0-48 of the observed LNG concentration from LNG PK samples at pre-dose through 48 hours post-dose. Standard noncompartmental techniques were used to determine CL/F using the software package Phoenix WinNonLin (Certara®).
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Oral Clearance (CL/F) of LNG
|
12.64 L/h
Interval 10.44 to 21.06
|
15.24 L/h
Interval 12.59 to 27.66
|
4.39 L/h
Interval 2.89 to 6.59
|
12.05 L/h
Interval 9.01 to 16.32
|
SECONDARY outcome
Timeframe: Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours post-dosePopulation: Participants who took assigned dose of LNG and prescribed doses of background drugs (ART or TB treatment) and who had LNG PK concentrations available over the sampling time frame.
Vd for each participant was calculated from observed LNG concentration from LNG PK samples at pre-dose through 48 hours post-dose. Standard noncompartmental techniques were used to determine Vd using the software package Phoenix WinNonLin (Certara®).
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Volume of Distribution (Vd) of LNG
|
276.70 L
Interval 118.28 to 411.82
|
294.92 L
Interval 208.7 to 489.52
|
169.05 L
Interval 93.83 to 215.16
|
156.31 L
Interval 105.26 to 247.2
|
SECONDARY outcome
Timeframe: Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours post-dosePopulation: Participants who took assigned dose of LNG and prescribed doses of background drugs (ART or TB treatment) and who had LNG PK concentrations available over the sampling time frame.
T1/2 for each participant was calculated using regression analysis when possible from the observed LNG concentration from LNG PK samples at pre-dose through 48 hours post-dose. Standard noncompartmental techniques were used to determine T1/2 using the software package Phoenix WinNonLin (Certara®).
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Half-life (T1/2) of LNG
|
12.05 hours
Interval 8.63 to 13.7
|
11.79 hours
Interval 10.58 to 13.8
|
24.03 hours
Interval 19.95 to 28.03
|
8.97 hours
Interval 6.72 to 11.89
|
SECONDARY outcome
Timeframe: Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours pose-dosePopulation: Participants who took assigned dose of LNG and prescribed doses of background drugs (ART or TB treatment) and who had LNG PK concentrations available over the sampling time frame.
Tmin for each participant was time to the minimum observed LNG concentration after the observed dose.
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Time of Minimum Concentration (Tmin) of LNG
|
47.07 hours
Interval 46.13 to 48.0
|
47.95 hours
Interval 46.13 to 48.0
|
47.61 hours
Interval 0.5 to 48.31
|
48.00 hours
Interval 46.55 to 48.0
|
SECONDARY outcome
Timeframe: Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post-dosePopulation: Participants who took assigned dose of LNG and prescribed doses of background drugs (ART or TB treatment) and who had LNG PK concentrations available over the sampling time frame.
AUC for each participant was calculated from all available LNG concentrations measured over 24 hours using the linear up/log down version of trapezoidal rule (i.e., noncompartmental technique) using the software package Phoenix WinNonLin (Certara®). This version of the trapezoidal rule used linear interpolation between untransformed data up to Cmax, and between log-transformed data from Cmax through Clast. Assay lower limit of quantification for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
LNG Area Under the Concentration Time Curve (AUC0-24h) Calculated Based on Intensive LNG PK Samples Obtained From Individual Participants
|
81.64 hours * ng/mL
Interval 56.14 to 128.49
|
153.40 hours * ng/mL
Interval 100.13 to 190.48
|
157.56 hours * ng/mL
Interval 132.3 to 282.32
|
213.69 hours * ng/mL
Interval 148.64 to 283.22
|
SECONDARY outcome
Timeframe: Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours pose-dosePopulation: Participants who took assigned dose of LNG and prescribed doses of background drugs (ART or TB treatment) and who had LNG PK concentrations available over the sampling time frame.
AUC for each participant was calculated from all available LNG concentrations measured over 48 hours using the linear up/log down version of the trapezoidal rule (i.e., noncompartmental technique) using the software package Phoenix WinNonLin (Certara®). This version of the trapezoidal rule used linear interpolation between untransformed data up to Cmax, and between log-transformed data from Cmax through Clast. Assay lower limit of quantification for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
LNG Area Under the Concentration Time Curve (AUC0-48h) Calculated Based on Intensive LNG PK Samples Obtained From Individual Participants
|
98.95 hours * ng/mL
Interval 66.38 to 141.27
|
180.25 hours * ng/mL
Interval 106.87 to 216.75
|
224.81 hours * ng/mL
Interval 178.3 to 400.9
|
242.68 hours * ng/mL
Interval 181.56 to 321.98
|
SECONDARY outcome
Timeframe: Intensive LNG PK samples at pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, and 48 hours pose-dosePopulation: Participants who took assigned dose of LNG and prescribed doses of background drugs (ART or TB treatment) and who had LNG PK concentrations available over the sampling time frame.
AUC for each participant was calculated from all available LNG concentrations measured to infinity hours using the linear up/log down version of trapezoidal rule (i.e., noncompartmental technique) using the software package Phoenix WinNonLin (Certara®). This version of the trapezoidal rule used linear interpolation between untransformed data up to Cmax, and between log-transformed data from Cmax through Clast. Assay lower limit of quantification for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).
Outcome measures
| Measure |
A: LNG 1.5 mg Among Participants on EFV-based ART (Randomized)
n=17 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Participants on EFV-based ART (Randomized)
n=35 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Participants on DTG-based ART (Assigned)
n=32 Participants
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Participants on RIF-INH TB Therapy (Assigned)
n=34 Participants
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
LNG Total Area Under the Concentration Time Curve AUCinf (Infinity) Calculated Based on Intensive LNG PK Samples Obtained From Individual Participants
|
118.71 hours * ng/mL
Interval 71.23 to 143.69
|
196.83 hours * ng/mL
Interval 108.48 to 238.24
|
345.80 hours * ng/mL
Interval 227.8 to 518.69
|
248.96 hours * ng/mL
Interval 183.87 to 333.05
|
Adverse Events
A: LNG 1.5 mg Among Women on EFV-based ART (Randomized)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
B: LNG 3.0 mg Among Women on EFV-based ART (Randomized)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C: LNG 1.5 mg Among Women on DTG-based ART (Assigned)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
D: LNG 3.0 mg Among Women on RIF-INH TB Therapy (Assigned)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: LNG 1.5 mg Among Women on EFV-based ART (Randomized)
n=17 participants at risk
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Women on EFV-based ART (Randomized)
n=36 participants at risk
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Women on DTG-based ART (Assigned)
n=35 participants at risk
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Women on RIF-INH TB Therapy (Assigned)
n=34 participants at risk
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Nervous system disorders
Epilepsy
|
0.00%
0/17 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/36 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/35 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
2.9%
1/34 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
Other adverse events
| Measure |
A: LNG 1.5 mg Among Women on EFV-based ART (Randomized)
n=17 participants at risk
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
B: LNG 3.0 mg Among Women on EFV-based ART (Randomized)
n=36 participants at risk
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
C: LNG 1.5 mg Among Women on DTG-based ART (Assigned)
n=35 participants at risk
Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
D: LNG 3.0 mg Among Women on RIF-INH TB Therapy (Assigned)
n=34 participants at risk
Participants received 3 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/36 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/35 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
2.9%
1/34 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/17 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/36 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/35 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
2.9%
1/34 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/36 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
2.9%
1/35 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
5.9%
2/34 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/36 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/35 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
2.9%
1/34 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
5.9%
1/17 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/36 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/35 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
2.9%
1/34 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/17 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/36 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/35 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
2.9%
1/34 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
0.00%
0/17 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/36 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
0.00%
0/35 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
2.9%
1/34 • From study entry to study completion at Day 28 or premature study discontinuation.
The DAIDS AE Grading Table (V2.1) and Addendum 1, Female Genital Grading Table for Use in Microbicide Studies, Version 1.0 - November 2007 were used. AEs were recorded on the case report forms (CRFs) if any of the following criteria had been met: * All Grade ≥3 AEs considered potentially or definitely related to LNG * All Grade ≥2 nausea, diarrhea, menorrhagia, or metrorrhagia * Ectopic pregnancy * All AEs meeting Serious Adverse Event (SAE) definition
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company.
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place